Trials / Withdrawn
WithdrawnNCT01047137
Response of Urticaria to Stress Intervention
Effect of Psychological Stress Intervention on Chronic Urticaria Activity and Immune Dysregulation
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- University of Mississippi Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years – 64 Years
- Healthy volunteers
- Not accepted
Summary
Several studies have shown a relationship between psychological stress and chronic urticaria (hives). The primary objective of this study is to evaluate the effect psychological stress intervention has on chronic urticaria.
Detailed description
As many patients with chronic urticaria display heightened levels of stress before and/or after the onset of the urticaria, the purpose of this study is to evaluate the effect of psychological stress intervention on chronic urticaria. Intervention group participants will meet with a psychiatry resident once a week for six consecutive weeks to be educated on psychological stress intervention techniques. Control group participants will meet with a psychiatry resident once a week for six consecutive weeks for general supportive therapy, which will not provide psychological stress intervention. All participants will complete a packet of psychological and dermatological questionnaires before the first session with the psychiatry resident and one week after the final session. All participants will record daily 1) their urticaria symptoms and 2) the type and number of antihistamines taken. Blood and saliva samples will be collected before the first session and one week after completion of the final session to compare the levels of stress hormones and cytokines in order to evaluate an effect on immune dysregulation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Psychological Stress Intervention | Intervention group participants will meet with a psychiatry resident once a week for six consecutive weeks to be educated on psychological stress intervention techniques focusing on relaxation, mindfulness, emotion regulation and acceptance and willingness. |
| BEHAVIORAL | General Supportive Therapy | There is no focus on stress intervention. |
Timeline
- Start date
- 2010-07-01
- Primary completion
- 2011-03-01
- Completion
- 2011-03-01
- First posted
- 2010-01-12
- Last updated
- 2018-02-20
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01047137. Inclusion in this directory is not an endorsement.